GMP-Driven Documentation Systems Specialist III

BlackRomance; Charlottesville (VA); Vor Ort; USD 34.000 - 48.000; Vollzeit

Zusammenfassung

Afton Scientific is seeking a Documentation Systems Specialist III to join our Quality Assurance team in Charlottesville. You will manage master documents, batch records, SOPs, and change controls, ensuring accuracy and regulatory compliance.

Responsibilities include administering MasterControl or Veeva, supporting audits, and coordinating document changes with cross-functional teams. Candidates should have a Bachelor's degree or 5+ years in pharmaceutical documentation and strong communication

Qualifikationen

• Bachelor's degree or minimum five years in pharmaceutical administration, documentation, or related role.
• General experience in biopharmaceutical production or Quality Control.
• Knowledge of cGMP and FDA/EU guidance for aseptic processing.
• Experience with GMP-compliant document management systems (MasterControl/Veeva).
• Advanced MS Word and Excel; ability to learn new database apps.
• Strong written and verbal communication; detail-oriented.

Aufgaben

• Manage and administer documentation systems (SOPs, batch records, specifications, change controls).
• Notify stakeholders of document changes and maintain change-tracking records.
• Assign lot numbers and issue batch records; write and edit master documents.
• Review and approve Change Control documentation and Operational Deviation Reports as applicable.
• Support audits and VIP visits by facilitating documentation requests.
• Provide general admin support and cross-functional assistance as qualified.

Kenntnisse

Attention to Detail

Documentation

Data Integrity

Quality & Regulatory Compliance

Organization

Communication

Problem Solving

Stakeholder Support

Ausbildung

Bachelor's degree or 5+ years experience

Tools

MasterControl

Veeva

GMP Document Management System

Jobbeschreibung

Afton Scientific is seeking a Documentation Systems Specialist III to join our Quality Assurance team in Charlottesville. You will manage master documents, batch records, SOPs, and change controls, ensuring accuracy and regulatory compliance.

Responsibilities include administering MasterControl or Veeva, supporting audits, and coordinating document changes with cross-functional teams. Candidates should have a Bachelor's degree or 5+ years in pharmaceutical documentation and strong communication